Percutaneous mitral valve replacement device

ABSTRACT

A prosthetic valve assembly includes a support structure and a valve component. The support structure includes a first frame and a sealing member. The first frame includes a lumen extending between inflow and outflow ends. The sealing member extends inwardly into the lumen of the first frame and includes a first end wall defining a first orifice, a second end wall axially spaced from the first end wall and defining a second orifice, and an inner sleeve extending axially from the first end wall to the second end wall and spaced radially inwardly from the first frame. The valve component includes a second frame and a valve structure supported inside of the second frame for permitting blood flow through the valve component in one direction and blocking blood flow in the opposite direction. The valve component is configured to expand within and engage the inner sleeve of the sealing member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/134,172, filed on Apr. 20, 2016, issuing as U.S. Pat. No. 10,441,416,which claims the benefit of U.S. Provisional Application No. 62/264,224,filed on Dec. 7, 2015, and U.S. Provisional Application No. 62/150,431,filed on Apr. 21, 2015. All of the prior applications are incorporatedby reference herein.

FIELD

The present disclosure generally concerns prosthetic heart valves anddevices and related methods for implanting such a heart valve.

BACKGROUND

The native heart valves (i.e., the aortic, pulmonary, tricuspid andmitral valves) serve critical functions in assuring the forward flow ofan adequate supply of blood through the cardiovascular system. Theseheart valves can be rendered less effective by congenital malformations,inflammatory processes, infectious conditions, or disease. Such damageto the valves can result in serious cardiovascular compromise or death.For many years the definitive treatment for such disorders was thesurgical repair or replacement of the valve during open heart surgery.However, such surgeries are highly invasive and are prone to manycomplications. Therefore, elderly and frail patients with defectiveheart valves often went untreated. More recently, transvasculartechniques have been developed for introducing and implanting prostheticdevices in a manner that is much less invasive than open heart surgery.Such transvascular techniques have increased in popularity due to theirhigh success rates.

A healthy heart has a generally conical shape that tapers to a lowerapex. The heart is four-chambered and comprises the left atrium, rightatrium, left ventricle, and right ventricle. The left and right sides ofthe heart are separated by a wall generally referred to as the septum.The native mitral valve of the human heart connects the left atrium tothe left ventricle. The mitral valve has a very different anatomy thanother native heart valves. The mitral valve includes an annulus portion,which is an annular portion of the native valve tissue surrounding themitral valve orifice, and a pair of cusps or leaflets extending downwardfrom the annulus into the left ventricle. The mitral valve annulus canform a “D” shaped, oval, or otherwise out-of-round cross-sectional shapehaving major and minor axes. The anterior leaflet can be larger than theposterior leaflet, forming a generally “C” shaped boundary between theabutting free edges of the leaflets when they are closed together.

When operating properly, the anterior leaflet and the posterior leafletfunction together as a one-way valve to allow blood to flow only fromthe left atrium to the left ventricle. The left atrium receivesoxygenated blood from the pulmonary veins. When the muscles of the leftatrium contract and the left ventricle dilates (also referred to as“ventricular diastole” or “diastole”), the oxygenated blood that iscollected in the left atrium flows into the left ventricle. When themuscles of the left atrium relax and the muscles of the left ventriclecontract (also referred to as “ventricular systole” or “systole”), theincreased blood pressure in the left ventricle urges the two leafletstogether, thereby closing the one-way mitral valve so that blood cannotflow back to the left atrium and is instead expelled out of the leftventricle through the aortic valve. To prevent the two leaflets fromprolapsing under pressure and folding back through the mitral annulustoward the left atrium, a plurality of fibrous cords called chordaetendineae tether the leaflets to papillary muscles in the leftventricle.

Mitral regurgitation occurs when the native mitral valve fails to closeproperly and blood flows into the left atrium from the left ventricleduring the systolic phase of heart contraction. Mitral regurgitation isthe most common form of valvular heart disease. Mitral regurgitation hasdifferent causes, such as leaflet prolapse, dysfunctional papillarymuscles, and/or stretching of the mitral valve annulus resulting fromdilation of the left ventricle. Mitral regurgitation at a centralportion of the leaflets can be referred to as central jet mitralregurgitation, and mitral regurgitation nearer to one commissure (i.e.,the location where the leaflets meet) of the leaflets can be referred toas eccentric jet mitral regurgitation.

In addition to mitral regurgitation, mitral narrowing or stenosis ismost frequently the result of rheumatic disease. While this has beenvirtually eliminated in developed countries, it is still common whereliving standards are not as high.

Similar to complications of the mitral valve are complications of theaortic valve, which controls the flow of blood from the left ventricleinto the aorta. For example, many older patients develop aortic valvestenosis.

One method for treating valvular heart disease includes the use of aprosthetic valve implanted within the native heart valve. Theseprosthetic valves can be implanted using a variety of techniques,including various transcatheter techniques, in which a prosthetic valveis mounted in a crimped or compressed state on the distal end portion ofa delivery catheter. The delivery catheter is then advanced through thepatient's vasculature until the prosthetic valve reaches theimplantation site. The valve at the catheter tip is then expanded to itsfunctional size at the site of the defective native valve such as byinflating a balloon on which the valve is mounted. Alternatively, aself-expanding prosthetic valve can be retained in a radially compressedstate within a sheath of a delivery catheter. After the distal end ofthe delivery catheter is advanced to the implantation site, theprosthetic valve can be deployed from the sheath, which allows theprosthetic valve to expand to its functional state.

Although prosthetic valves for implantation at the aortic valve arewell-developed, catheter-based prosthetic valves are not necessarilyapplicable to the mitral valve due to the distinct differences betweenthe aortic and mitral valves. For example, the mitral valve has acomplex subvalvular apparatus, i.e., chordae tendineae, which is notpresent in the aortic valve. Additionally, the native mitral valveannulus typically does not provide sufficient structure for anchoringand resisting migration of a prosthetic valve.

In recent years, significant efforts have been made in developingprosthetic valves for implantation at the native mitral valve. However,these prosthetic valves can require very difficult and accurateplacement which, in turn, leads to unsuccessful or undesirable placementor long procedural times. These constraints can adversely affect apatient's health both during and after the implantation procedure oreven prevent some patients from being able to undergo the procedure alltogether.

As such, there is a continuing need for improved prosthetic valves, aswell as methods for implanting such prosthetic valves.

SUMMARY

Described herein are embodiments of prosthetic heart valves andcomponents thereof that are primarily intended to be implanted at one ofthe native mitral, aortic, tricuspid, or pulmonary valve regions of ahuman heart, as well as methods for implanting the same. Theseprosthetic heart valves can be used to help restore and/or replace thefunctionality of a defective native heart valve. The prosthetic heartvalves can comprise projections which are configured to engage thetissue of the native heart valve leaflets to position and secure theprosthetic heart valve in the native heart valve region.

In one representative embodiment, a prosthetic valve assembly forreplacing a native heart valve comprises a radially expandable andcompressible support structure, the support structure comprising anannular frame having a lumen extending from an inflow end to an outflowend, the support structure further comprising an annular sealing memberextending radially inwardly into the lumen of the frame and having aninner peripheral portion defining an orifice, and a radially expandableand compressible valve component, the valve component comprising anannular frame and a valve structure supported inside of the frame forpermitting the flow blood through the valve component in one directionand blocking the flow of blood in the opposite direction, wherein thevalve component is configured to expand within the orifice of thesealing member and engage the inner peripheral portion of the sealingmember when radially expanded.

In some embodiments, the prosthetic valve assembly further comprises aflexible, tubular connector connected at one end to the supportstructure and at another end to the valve component, the connectorpermitting the valve assembly to transition from a first, axiallyextended configuration wherein the valve component is outside of thesupport structure and a second, axially contracted configuration whereinthe valve component is at least partially within the support structure.In some embodiments, the sealing member comprises a fabric.

In some embodiments, the support structure comprises a plurality ofprojections secured to the outside of the frame of the supportstructure, the projections having first ends secured to the frame of thesupport structure and second ends formed as barbs for engaging andpenetrating tissue of the native heart valve. In some embodiments, theframes of the support structure and the valve component are sized suchthat when the valve component is expanded within the support structure,a radially and axially extending gap is defined between the frames alongthe entire length of the valve component.

In some embodiments, there are no metal components connecting the framesto each other. In some embodiments, the frames are connected to eachother only by fabric.

In some embodiments, the sealing member comprises a first end walldefining a first orifice, a second wall axially spaced from the firstend wall and defining a second orifice, and a tubular, inner sleeveextending from the first orifice of the first end wall to the secondorifice of the second end wall, and wherein the valve component isconfigured to be deployed within the inner sleeve. In some embodiments,each of the end walls and the inner sleeve comprises fabric. In someembodiments, the sealing member comprises an outer sleeve extending overthe outer surface of the frame of the support structure from the firstend wall to the second end wall.

In another representative embodiment, a prosthetic valve assembly forreplacing a native heart valve, comprises a radially expandable andcompressible support structure, the support structure comprising anannular frame having a lumen extending from an inflow end to an outflowend, an annular sealing member extending radially inwardly into thelumen of the frame and having an inner peripheral portion defining anorifice, and a radially expandable and compressible tubular valvecomponent coupled to the sealing member inside of the support structure,the valve component comprising a plurality of leaflets configured topermit the flow blood through the valve component in one direction andblock the flow of blood in the opposite direction, wherein the sealingmember comprises a first end wall defining a first orifice, a secondwall axially spaced from the first end wall and defining a secondorifice, and a tubular, inner sleeve extending from the first orifice ofthe first end wall to the second orifice of the second end wall, andwherein the valve component is mounted inside of the inner sleeve.

In some embodiments, the valve component comprises an annular frame andthe leaflets are mounted inside of the frame of the valve component. Insome embodiments, the prosthetic valve assembly further comprises aflexible, tubular connector connected at one end to the supportstructure and at another end to the valve component, the connectorpermitting the valve assembly to transition from a first, axiallyextending configuration wherein the valve component is outside of thesupport structure and a second, axially contracted configuration whereinthe valve component is at least partially within the support structure.

In some embodiments, the support structure and the valve componentdefine a radially and axially extending gap between the frame, thesupport structure, and the valve component along the entire length ofthe valve component when the support structure and the valve componentare expanded.

In some embodiments, there are no metal components connecting the frameof the support structure to the valve component. In some embodiments,the frame of the support structure and the valve component are connectedto each other only by fabric.

In another representative embodiment, a prosthetic valve assembly forreplacing a native heart valve comprises a radially expandable andcompressible support structure, the support structure comprising anannular frame having a lumen extending from an inflow end to an outflowend, a blood-impermeable tubular sleeve disposed inside of the frame ofthe support structure, the sleeve having a lumen extending from aninflow end to an outflow end, wherein the inflow end of the sleeve isspaced radially inward of the inflow end of the frame of the supportstructure, and a plurality of leaflets supported inside of the sleeveand configured to permit blood to flow through the valve assembly in onedirection and block the flow of blood in the opposite direction.

In some embodiments, the leaflets are stitched to the sleeve. In someembodiments, the leaflets are supported inside of another annular framethat is disposed within the sleeve. In some embodiments, the prostheticvalve assembly further comprises first and second, axially spaced apart,blood-impermeable end walls, the first end wall extending radiallyinwardly from the frame of the support structure and having an innerperipheral edge defining an orifice and secured to the inflow end of thesleeve, the second end wall extending radially inwardly from the frameof the support structure and having an inner peripheral edge defining anorifice and secured to the outflow end of the sleeve.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a frame of a prosthetic heart valve,according to one embodiment.

FIG. 2 is a perspective view of an exemplary embodiment of a prostheticheart valve comprising the frame of FIG. 1 .

FIG. 3 is a perspective view of the prosthetic heart valve of FIG. 2positioned within a native mitral valve of a heart, which is shown inpartial cross-section.

FIG. 4 is a perspective view of an exemplary embodiment of a deliveryapparatus delivering and positioning a prosthetic heart valve in anative mitral valve of a heart, which is shown in partial cross-section.

FIG. 5 is a side view of another exemplary embodiment of a prostheticheart valve.

FIG. 6 is a side view of an exemplary prosthetic valve, according toanother embodiment.

FIG. 7 is a perspective view of a prosthetic valve assembly shown in adeployed configuration, according to another embodiment.

FIG. 8 is a top plan view of a prosthetic valve assembly shown in adeployed configuration, according to another embodiment.

FIG. 9 is a perspective view of the prosthetic valve assembly of FIG. 8shown in an axially extended configuration, as viewed from the inflowend of the assembly.

FIG. 10 is a perspective view of the prosthetic valve assembly of FIG. 8shown in an axially extended configuration, as viewed from the outflowend of the assembly.

FIG. 11 is a side view of the prosthetic valve assembly of FIG. 8 shownin an axially extended configuration.

FIG. 12 is a top plan view of the inner and outer frames of theprosthetic valve assembly of FIG. 7 .

FIG. 13 is a perspective view of the inner and outer frames shown inFIG. 12 .

FIGS. 14-17 are top plan views of different embodiments of sealingmembers that can be incorporated in a prosthetic valve assembly.

FIGS. 18-21 show an embodiment of a delivery apparatus in various stagesof deploying the prosthetic valve assembly of FIG. 8 .

FIGS. 22-25 show the valve assembly of FIG. 8 being implanted in thenative mitral valve using the delivery apparatus shown in FIGS. 18-21 .

FIG. 26 is a perspective view of a prosthetic valve assembly as viewedfrom the inflow end of the valve assembly, according to anotherembodiment.

FIG. 27 is a perspective view of the prosthetic valve assembly of FIG.26 , as viewed from the outflow end of the valve assembly.

FIG. 28 is a perspective view of the support structure of the valveassembly of FIG. 26 , as viewed from the inflow end of the supportstructure.

FIG. 29 is a perspective view of the support structure of FIG. 28 , asviewed from the outflow end of the support structure.

FIG. 30 is a top plan view of two frames that can be used in the valvecomponent and the support structure of the prosthetic valve assembly ofFIG. 26 .

FIGS. 31-33 show an embodiment of a delivery apparatus in various stagesof deploying the prosthetic valve assembly of FIG. 26 .

FIG. 34 is a perspective view of a prosthetic valve assembly as viewedfrom the inflow end of the valve assembly, according to anotherembodiment.

FIG. 35 is a perspective view of the prosthetic valve assembly of FIG.34 , as viewed from the outflow end of the valve assembly.

FIG. 36 is a side view of a frame structure of a prosthetic valve,according to another embodiment.

FIG. 37 is a top plan view of the frame structure of FIG. 36 .

FIGS. 38-41 show an embodiment of a delivery apparatus in various stagesof deploying a prosthetic valve in a native mitral valve of a heart.

DETAILED DESCRIPTION

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatuses, and systems should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The methods, apparatuses, and systems are not limited toany specific aspect or feature or combination thereof, nor do thedisclosed embodiments require that any one or more specific advantagesbe present or problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language. Forexample, operations described sequentially may in some cases berearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods can be used in conjunction with other methods.

As used herein, the terms “a”, “an” and “at least one” encompass one ormore of the specified element. That is, if two of a particular elementare present, one of these elements is also present and thus “an” elementis present. The terms “a plurality of” and “plural” mean two or more ofthe specified element.

As used herein, the term “and/or” used between the last two of a list ofelements means any one or more of the listed elements. For example, thephrase “A, B, and/or C” means “A,” “B,” “C,” “A and B,” “A and C,” “Band C” or “A, B and C.”

As used herein, the term “coupled” generally means physically coupled orlinked and does not exclude the presence of intermediate elementsbetween the coupled items absent specific contrary language.

Described herein are embodiments of prosthetic heart valves andcomponents thereof that are primarily intended to be implanted at one ofthe native mitral, aortic, tricuspid, or pulmonary valve regions of ahuman heart, as well as methods for implanting the same. The prostheticvalves can be configured to engage the tissue of the native heart valveleaflets to position and secure the prosthetic heart valve in the nativeheart valve region. These prosthetic heart valves can be used to helprestore and/or replace the functionality of a defective native heartvalve.

In particular embodiments, a prosthetic heart valve assembly can beconfigured to be implanted at or adjacent to the native mitral valve andcomprises a frame to which a prosthetic valve structure is attached. Theprosthetic heart valve assembly can be delivered and implanted in aminimally invasive manner (e.g., transapical, transventricular,transatrial, transseptal, etc.) within the left ventricle and/or theleft atrium.

In particular embodiments, a frame of a prosthetic heart valve assemblycomprises a plurality of projections which extend radially outward fromthe prosthetic heart valve assembly. The projections can be configuredto engage and penetrate the tissue of a native heart valve leaflet tosecure and/or eliminate or decrease migration of a prosthetic valvewithin the native valve region.

In particular embodiments, the frame can comprise an atrial flange whichcan assist in securing a prosthetic heart valve assembly within thenative heart valve region and/or eliminate or reduce paravalvularleakage (i.e., leakage around the prosthetic heart valve afterimplantation).

Referring first to FIG. 2 , there is shown an exemplary embodiment of aprosthetic heart valve 10. The prosthetic heart valve 10 can comprise aframe 12 and a valve structure 14 supported by and/or within the frame12. The valve structure 14 can include a plurality of prostheticleaflets 16 (three shown in the illustrated embodiment) and/or othercomponents for regulating the flow of blood in one direction through theprosthetic heart valve 10. The valve structure 14 can be oriented withinthe frame 12 such that an upper end 18 of the valve structure 14 is aninflow end and a lower end 20 of the valve structure 14 is an outflowend. The valve structure 14 can comprise any of various suitablematerials, such as natural tissue (e.g., bovine pericardial tissue) orsynthetic materials. The prosthetic valve 10 can comprise an annularmain body 15 that supports the valve structure 14 and an atrial sealingmember 17 extending from the atrial end of the main body 15.

It will be appreciated by those of ordinary skill in the art that thevalve structure 14 can be mounted to the frame 12 using suitabletechniques and mechanisms. Additional details regarding components andassembly of prosthetic valves (including techniques for mountingleaflets to the frame) are described, for example, in U.S. PatentApplication Publication Nos. 2009/0276040 A1, 2010/0217382 A1, and2014/0222136 A1 and U.S. Pat. No. 8,449,599, which are each incorporatedby reference herein.

Referring now to FIG. 1 , the frame 12 can comprise a tubular main body22 and, optionally, an enlarged atrial flange 24 extending both radiallyoutward and axially upward from an atrial end 26 of the main body 22.The frame 12 is desirably covered with a blood-impervious cover 32, asfurther described below. The atrial flange 24 of the frame supports anupper portion of the cover 32, effectively forming the atrial sealingmember 17 of the prosthetic valve 10.

The frame 12 can be configured in this manner, for example, byintegrally forming the main body 22 and/or the atrial flange 24 from asingle piece of material. This can be accomplished, for example, bylaser cutting a tube or forming the frame 12 from a wire mesh. In otherembodiments, the frame 12 can be formed from separate pieces of materialwhich are fixedly secured or coupled together. The separate pieces canbe fixedly secured together, for example, by welding, soldering,fasteners, etc.

In an alternative embodiment, the frame 12 can be configured without anatrial flange, as shown in FIG. 5 . In another alternative embodiment,the main body 22 can include an atrial flange portion 30 which extendsradially outward from the atrial end 26 of the main body 22 andfunctions similarly to the atrial flange 24, as shown in FIG. 6 .

The prosthetic valve 10 can be radially collapsible and expandablebetween a radially expanded state (FIGS. 1-6 ) and a radially compressedstate (not shown) to enable delivery and implantation at the mitralvalve region of the heart (or within another native heart valve). Theframe 12 can be formed from a flexible, shape-memory material, such asNitinol, to enable self-expansion from the radially compressed state tothe radially expanded state, as further described below. In alternativeembodiments, the frame 12 can be plastically expandable from a radiallycompressed state to an expanded state by an expansion device, such as aninflatable balloon. Such plastically expanding frames can be formed fromstainless steel, chromium alloys, and/or other suitable materials.

In the expanded state, the main body 22 of the frame 12 can form anopen-ended tube. The valve structure 14 can be coupled to an innersurface of the frame 12 and can be retained within the lumen formed bythe main body 22, as best shown in FIG. 2 . The main body 22 can havedimensions substantially similar to or slightly larger than that of themitral orifice, i.e., the inner surface of the mitral valve annulus 104,such that the main body 22 can engage the inner surface of the mitralvalve annulus 104 and native leaflets 110, as further described below.

For example, in the nominal outer diameter of the main body 22 can beabout 20 mm to about 55 mm. In some embodiments, the nominal outerdiameter of the main body 22 can be about 25 mm to about 40 mm. In oneparticular embodiment, the nominal outer diameter of the main body 22 isabout 29 mm.

The main body 22 of the frame 12 can comprise a plurality ofinterconnected angled struts 34, a plurality of tissue-engagingprojections 36, and at least one positioning member 38 (three in theillustrated embodiment). The projections 36 can be connected to andextend from the struts 34 both radially outward and axially upwardtoward the atrial end 26 of the main body 22. The projections 36 can bedistributed circumferentially and axially on the main body 22 relativeto each other. The positioning members 38 can also be connected to thestruts 34 and can extend axially downward from a ventricular end 28 ofthe main body 22.

For example, in the illustrated embodiment, the struts 34 are arrangedin circumferentially extending rows connected to each other to form adiamond lattice pattern with the struts 34 intersecting at apices orjunctions 40. The projections 36 and positioning members 38 areconnected to and each extend from the respective junctions 40 of thestruts 34. In alternative embodiments, the struts 34 can be arranged invarious other patterns, and the projections 36 and the positioningmembers 38 can be connected to the struts at various other positions andin various ways.

The projections 36 can be configured to engage or penetrate the tissueof the native heart valve leaflets. For example, as shown in FIG. 3 ,the projections 36 can penetrate into the native leaflets 110 (i.e., thenative anterior leaflet 110 a and the native posterior leaflet 110 b) asthe projections extend radially outward from the main body 22 andaxially upward toward the atrial end 26 of the main body 22.

Configuring the projections 36 in this manner can allow the hemodynamicpressure to assist in the initial placement as well as retention of theprosthetic valve 10 within a native heart valve (e.g., a native mitralvalve). For example, when the prosthetic valve 10 is placed in thenative mitral valve 102, the hemodynamic pressure during the systolicphase of heart contraction causes the prosthetic valve 10 to moveslightly upwardly toward the left atrium 108, causing the projections 36to penetrate the tissue of the native leaflets 110, as best shown inFIG. 3 .

Once the prosthetic valve 10 is initially placed within the nativemitral valve 102, the axially upward angle of the projections 36 canhelp maintain the axial positioning of the prosthetic valve 10 relativeto the native leaflets 110. This is because the hemodynamic pressuretends to force the prosthetic valve 10 toward the left atrium 108 (i.e.in the direction of shown by arrow 112) during systole, but the angledprojections 36 resist this force by urging the projections 36 fartherinto the native leaflets 110 as the prosthetic valve 10 attempts to movetoward the left atrium 108.

In some embodiments, the projections 36 can each include a hook or barb42 disposed near the distal, free end of the respective projections 36,as best shown in FIG. 1 . The barbs 42 can resist the projections 36from being pulled out of the native leaflets and/or resist theprosthetic valve 10 from moving toward the left ventricle 106 (i.e., inthe direction of shown by arrow 114) under the pressure gradient forceof the blood flowing from the left atrium into the left ventricle.

In alternative embodiments, the projections 36 can be configured withoutthe barbs, as shown in FIG. 4 . Configuring the projections 36 withoutthe barbs can allow the prosthetic valve 10 to be repositionedrelatively more easily (i.e., compared to a valve comprising projectionswith barbs) once the projections 36 initially penetrate the nativeleaflets 110, as further described below.

The positioning members 38 can be configured to assist in the deliveryand/or positioning of the prosthetic valve 10 within a native heartvalve. In the illustrated embodiment, the positioning members 38 areloops or eyelets which can be used to releasably connect the prostheticvalve 10 to a delivery apparatus, as further described below.

As shown, the projections 36 and the positioning members 38 can bedistributed symmetrically on the main body 22, respectively. However,the projections 36 and the positioning members 38 can be distributedasymmetrically on the main body 22, respectively.

In the expanded state, the atrial flange 24 can be generallyfrustoconical and extend both radially outward and axially upward fromthe atrial end 26 of main body 22. The atrial flange 24 be connected tothe main body 22 by a plurality of connecting members 44 (nine in theillustrated embodiment). As best shown in FIG. 2 , the connectingmembers 44 can be distributed circumferentially around the atrial flange24 and can each be connected to a respective junction 40 at the atrialend 26 of the main body 22.

The atrial sealing member 17 can be sized and shaped to contact theatrial side of the mitral valve annulus 104 and tissue of the leftatrium 108 when the frame 12 is implanted, as best shown in FIG. 3 . Theatrial sealing member 17 can also be sized such that when the prostheticvalve 10 is implanted in the native mitral valve 102, the sealing member17 completely covers the opening between the native leaflets 110, asshown in FIG. 3 . The atrial sealing member 17 can comprise a generallycircular, oval, or other circumferential shape that generallycorresponds to the native geometry of the left atrium 108 and the mitralvalve annulus 104. The contact between the atrial sealing member 17 andthe tissue of the left atrium 108 and the mitral valve annulus 104 canpromote tissue ingrowth with the cover 32, which can improve retentionand reduce paravalvular leakage. The atrial sealing member also ensuresthat all, or substantially all, of the blood passes through the one-wayvalve as it flows from the left atrium to the left ventricle.

For example, the nominal outer diameter of the atrial sealing member 17can be about 35 mm to about 70 mm. In some embodiments, the nominalouter diameter of the atrial sealing member 17 can be about 38 mm toabout 60 mm. In one particular embodiment, the nominal outer diameter ofthe atrial sealing member 17 is about 55 mm.

As shown in FIGS. 2-6 , the blood-impervious cover 32 can be connectedto the inner and/or outer surfaces of the main body 22 and the atrialflange 24 to form at least one layer or envelope covering the openingsin the frame 12. It will be appreciated by those of ordinary skill inthe art that the cover 32 can be connected to the frame 12 in variousways, such as by sutures.

The cover 32 can form a fluid-occluding and/or flange that can at leastpartially block the flow of blood through and/or around the frame 12 toreduce paravalvular leakage and can promote tissue ingrowth with theframe 12. The cover 32 can, for example, provide a mounting surface, orscaffold, to which the portions of the valve structure 14, such as theprosthetic leaflets 16, can be secured, as shown in FIG. 2 . Configuringthe cover 32 in this manner can allow the prosthetic valve 10 to directblood to flow between the prosthetic leaflets 16.

The cover 32 can comprise a semi-porous fabric that blocks blood flowbut can allow for tissue ingrowth. The cover 32 can comprise syntheticmaterials, such as polyester material or a biocompatible polymer. Oneexample of a polyester material is polyethylene terephthalate (PET).Alternative materials can be used. For example, the layer can comprisebiological matter, such as natural tissue, pericardial tissue (e.g.,bovine, porcine, or equine pericardium) or other biological tissue.

The prosthetic valve 10 can be delivered to a native heart valve withvarious delivery apparatuses and delivery techniques (e.g.,transventricular, transatrial, transseptal, etc.). For example, FIG. 4shows the prosthetic valve 10 being delivered to a native mitral valve102 with an exemplary embodiment of a delivery apparatus 200 using atransventricular technique.

The devices described herein (e.g., the prosthetic valve 10 and thedelivery apparatus 200) are described in the context of replacing orrepairing a native mitral valve. However, it should be understood thatthe devices can be used to replace or repair the other native heartvalves (i.e., the aortic, pulmonary, and tricuspid).

The delivery apparatus 200 can comprise an introducer 202, a guide wireshaft 204 having a nose cone 210 at a distal end thereof, a delivercatheter 205, and a plurality of positioning cords or tethers 206 (twoin the illustrated embodiment). The delivery catheter 205, the guidewire shaft 204, and the positioning cords 206 can extend co-axiallythrough a lumen 208 of the introducer 202. The introducer 202, thedelivery catheter 205, the guide wire shaft 204, and the positioningcords 206 can each be axially moveable relative to each other.

The delivery catheter 205 can be used to deliver the prosthetic valve 10to the native mitral valve in the radially compressed state. In someembodiments, the distal end portion of the delivery catheter 205 cancomprise a sheath that is used to retain the prosthetic valve 10 in theradially compressed state (e.g., when the frame 12 is formed from aself-expanding material such as Nitinol). Once the prosthetic valve 10is disposed in the native mitral valve 102, the sheath of the deliverycatheter 204 can be retracted and/or the prosthetic valve 10 can beadvanced distally from the sheath, allowing the prosthetic valve 10 toradially self-expand to its functional configuration.

The positioning cords 206 can be formed from flexible material such as awire or suture. The distal ends 216 of the positioning cords 206 can bereleasably connected to the positioning members 38. The positioningcords 206 can be used to adjust the axial positioning of the prostheticvalve 10, as further described below. In some embodiments, thepositioning cords 206 can also be used to retract the prosthetic valve10 back into the delivery catheter after the prosthetic valve has beeninitially deployed.

When using the delivery apparatus 200 to deliver the prosthetic valve 10transventricularly, the introducer 202 can be inserted through asurgical opening formed in the patient's chest and in the wall of theleft ventricular 106 (e.g., at the bare spot on the lower anteriorventricle wall of heart 100 (FIG. 4 )) until the distal end 212 of theintroducer 202 resides in the left ventricle 106, as shown in FIG. 4 .

The positioning of the delivery apparatus 200 and the prosthetic valve10 can be confirmed visually using imaging modalities such asfluoroscopy, X-ray, CT or MR imaging. Echocardiography in either 2D or3D can also be used to help guide the positioning of the deliveryapparatus 200 and the prosthetic valve 10.

Although not shown, a standard purse string suture can be used to holdthe introducer 202 in place against the heart 100 and prevent bloodleakage around the introducer 202, as well as seal the opening in theheart 100 upon removal of the introducer 202. The introducer 202 caninclude an internal sealing mechanism (e.g., hemostasis seal) to preventblood leakage through the lumen 208 of introducer 202.

With the prosthetic valve 10 in the radially compressed state within thedelivery catheter 205 and releasably attached to the positioning cords206, the delivery catheter 204 can then be inserted into the patient'sheart 100. This is accomplished by advancing the delivery catheter 205(i.e., in the direction shown by arrow 112) through the lumen 208 of theintroducer 202, through the left ventricle 106, and into the nativemitral valve 102 and/or left atrium 108. The prosthetic valve 10 can bepositioned relative the native mitral valve 102 such that the atrialsealing member 17 is in the left atrium 108, beyond the mitral valveannulus 104. The prosthetic valve 10 can then be radially expanded intoits functional configuration, such as by deploying the prosthetic valve10 from the delivery catheter 205.

Expansion of the prosthetic valve 10 causes the projections 36 to engagethe native leaflets 110. In some embodiments, the expansion force of theprosthetic valve 10 in conjunction with the hemodynamic pressure thaturges the prosthetic valve 10 upwardly toward the left atrium 108 causesthe projections 36 to penetrate the native leaflets 110, therebysecuring the prosthetic valve 10 in place. In certain embodiments, theradial expansion of the prosthetic valve is sufficient to cause theprojections to penetrate the native leaflets.

Once the projections 36 engage the native leaflets 110 and theprosthetic valve 10 is desirably positioned within the native mitralvalve 102, the positioning cords 206 can be detached from thepositioning members 38 and retracted through the lumen 208 of theintroducer 202, and the delivery catheter 205 can be retracted as well.

If, however, the prosthetic valve 10 is initially undesirably positionedwhen the projections 36 engage the native leaflets 110, the positioningcords 206 can be used to retract the projections 36 from the nativeleaflets 110 and to reposition the prosthetic valve 10 as desired. Forexample, FIG. 4 shows the prosthetic valve 10 undesirably positioned. Asshown, the prosthetic valve 10 is, for example, axially positioned toofar into the left atrium 108. This positioning can prevent theprosthetic valve 10 from effectively sealing against the native mitralvalve 102 because the atrial sealing member 17 (FIG. 1 ) is not incontact with the mitral valve annulus 104. Also, some of the projections36 are not engaging the native leaflets 110, which reduces the stabilityof the prosthetic valve 10 relative to the native mitral valve 102.

The prosthetic valve 10 can be repositioned by retracting thepositioning cords 206 axially (i.e., in the direction shown by arrow114), which in turn causes the prosthetic valve 10 to move axially inthe same direction. The axial movement of the prosthetic valve 10 towardthe left ventricle 106 causes the projections 36 to withdraw from ordisengage the native leaflets 110 and allows the prosthetic valve 10 tobe repositioned. Additionally, moving the delivery catheter 205 distallyover the positioning cords 206 draws the cords closer together radiallyand at least partially radially collapses the outflow end of theprosthetic valve to assist with the repositioning of the prostheticvalve.

The prosthetic valve 10 can then be moved axially such that the atrialsealing member 17 contacts the native mitral valve annulus 104, as shownin FIG. 3 . As the operator releases tension on the positioning cords206 and/or retracts the delivery catheter 205 to fully expand theoutflow end of the prosthetic valve, the hemodynamic pressure and/or theradial expansion force of the prosthetic valve cause the projections 36to re-engage and penetrate the native leaflets 110. Once the prostheticvalve is secured to the native leaflets 110, the delivery apparatus 200can be removed from the patient's body, as described above.

In some embodiments, the prosthetic valve 10 can be retrieved back intothe delivery catheter 205 by collapsing the outflow end of theprosthetic valve 10 sufficiently such that the prosthetic valve 10 canbe pulled back into the delivery catheter 205 and/or the deliverycatheter 205 can advanced distally over the prosthetic valve 10. Thefully retrieved valve can then be redeployed or removed from thepatient's body, if desired.

Referring now to FIG. 7 , there is shown a prosthetic valve assembly300, according to another embodiment. The prosthetic valve assembly 300in the illustrated embodiment comprises an outer support structure 302,a valve component 304, and a tubular flexible connector or sleeve 306extending between and connecting the support structure 302 to the valvecomponent 304. The prosthetic valve assembly 300 can be transitionedfrom an axially extended configuration in a delivery state in which thevalve component 304 is axially spaced from the support structure 302(FIGS. 9-11 ) and an axially contracted configuration in an implanted ordeployed state in which the valve component 304 is positioned at leastpartially within the support structure 302 (FIGS. 7-8 ), as furtherdescribed below.

The support structure 302 is configured to be implanted in a nativevalve annulus (e.g., the native mitral valve annulus) and provide astable support or platform for supporting the valve component 304. Thesupport structure 302 can be radially compressible and expandable andcan comprise a stent or frame 308 and a blood-impermeable cover, liner,or sleeve 310 supported on the outside of the frame 308 (as shown)and/or on the inside of the frame 308. The cover 310 can extend theentire length of the frame 308 and cover the entire outer surface of theframe as shown, or alternatively, extend along less than the entirelength of the frame.

The frame 308 can be formed from a shape memory material (e.g., Nitinol)to enable self-expansion of the support structure 302. Alternatively,the frame 308 can be formed from a plastically-expandable material(e.g., stainless steel, chromium alloys) and is configured to beexpanded by an expansion device, such as an inflatable balloon.

As best shown in FIG. 12 , the frame 308 can comprise a generallytubular main body 312 and an atrial flange 314 extending radiallyoutwardly from an atrial end of the main body 312. The frame 308 cancomprise a plurality of interconnected angled struts 316 and a pluralityof tissue-engaging projections 318. The atrial flange 314 can be formedby bending the upper row of struts 316 away from the main body 312 andshape-setting the frame in that configuration. The cover 310 can coverthe outside of the atrial flange 314, thereby forming an atrial sealingmember 315 of the support structure 302. The projections 318 can bedistributed circumferentially and/or axially on the outside of the frameand can include barbs 320, similar to projections 36 described above inconnection with FIG. 1 . Thus, the support structure 302 can be deployedand anchored within the native mitral valve annulus utilizing theprojections 318 and/or the atrial flange 314 in the same manner as theprosthetic valve 10.

In particular embodiments, as depicted in FIGS. 8-11 , the frame 308 canbe formed without an atrial flange that extends radially away from themain body 312 (similar to the frame 12 of FIG. 5 ). In otherembodiments, the frame 308 can have the same configuration as the 12 ofFIG. 1 .

The valve component 304 can be radially compressible and expandable andcan comprise a stent or frame 322 and a blood-impermeable cover or liner324 supported on the outside of the frame 322 (as shown) and/or on theinside of the frame 322. The frame 322 can be formed from a shape memorymaterial (e.g., Nitinol) to enable self-expansion of the valve component304. Alternatively, the frame 322 can be formed from aplastically-expandable material (e.g., stainless steel, chromium alloys)and configured to be expanded by an expansion device, such as aninflatable balloon.

A blood-regulating valve structure 326 can be supported inside of theframe 322 for regulating the one-way flow of blood through the valveassembly 300. The valve structure 326 can comprise, for example, one ormore flexible leaflets 328.

In particular embodiments, the outer diameter of the fully expandedvalve component 304 can be smaller than the inner diameter of the fullyexpanded support structure 302. Thus, when fully deployed (as shown inFIG. 7 ), the valve component 304 can be said to be “suspended” or“float” within the support structure 302. As best shown in FIGS. 12-13and 25 , for example, the outer diameter of the fully expanded frame 322of the valve component can be smaller than the inner diameter of thefully expanded frame 308 of the support structure 302 such that there isa radially and axially extending gap between the frames 308, 322 alongthe entire length of the frame 322. Referring to FIGS. 12 and 13 , theframe 308 of the support structure 302 can be referred to as an “outerframe” of the valve assembly 300 while the frame 322 of the valvecomponent 304 can be referred to as an “inner frame” of the valvecomponent 300 due to the position of the frame 322 relative to the frame308 when the assembly is fully deployed.

In particular embodiments, the frame 308 of the support structure 302has a diameter measured at the middle of the frame (equidistant from theinflow and outflow ends) of about 35 mm to about 50 mm and the frame 322of the valve component 304 has a diameter measured at the middle of theframe (equidistant from the inflow and outflow ends) of about 25 mm toabout 29 mm.

Referring again to FIGS. 7 and 8 , the support structure 302 can includean inner sealing member 330 that extends radially inwardly from theframe 308 at or adjacent the atrial end of the frame 308. The sealingmember 330 has an inner peripheral edge that defines an inner orifice332 that receives and supports an inflow end portion of the valvecomponent 304. In this manner, the sealing member 330 forms an annularend wall having an outer major surface 350 facing in the axial directionthat blocks the flow of blood into the annular space between the supportstructure and the valve component when the valve component is deployedwithin the support structure.

In particular embodiments, the sealing member 330 functions to securethe valve component 304 in place at least against hemodynamic pressureduring the diastolic phase of heart contraction; that is, the sealingmember 300 can prevent migration of the valve component 304 toward theleft ventricle during diastole. The sealing member 300 can comprise, forexample, one or more layers of a blood-impermeable fabric (e.g., PET)and can be an extension of the cover 310. In alternative embodiments,the sealing member 300 can be separately formed from the cover 310 andattached to the frame 308 using suitable techniques (e.g., sutures).

FIG. 14 shows the construction of a sealing member 330, according to oneembodiment. The sealing member 330 in this embodiment can include aplurality of strips of material 334 a, 334 b, 334 c, 334 d (e.g., fabricstrips) oriented at different angles relative to each other and atdifferent angular positions relative to the center of the sealingmember. The strips 334 a-334 d may be layered on a toroid shape piece ofmaterial (e.g., layer of fabric). The strips 334 a-334 d render thesealing member much less extensible or stretchable in the radialdirection to resist enlargement or dilation of the orifice 332 when thevalve component 304 is deployed within the sealing member 330. Thesealing member 330 can also include a thin, continuous piece of flexiblematerial 336 circumscribing the orifice 332, such as a suture, chord, orstring, that resists enlargement of the orifice 332.

FIG. 15 shows the construction of a sealing member 330, according toanother embodiment. The sealing member 330 in this embodiment cancomprise one or more stacked layers 338 of a toroid shaped material(e.g., fabric) that is reinforced with a plurality of radially extendingstruts 340 to resist enlargement of the orifice 332. The struts 340 cancomprise, for example, relatively flexible material, such as suturematerial or a stronger or heavier fabric than that used to form thelayer 338. Alternatively, the struts 340 can be formed from thin piecesof a biocompatible polymer or metal (e.g., stainless steel or Nitinol).

FIG. 16 shows the construction of a sealing member 330, according toanother embodiment. The sealing member 330 is this embodiment cancomprise two or more stacked, toroid-shaped layers 338 of fabricarranged such that the warp and weft fibers of one layer extend atdifferent angles of the warp and weft fibers from another layer. Forexample, in FIG. 16 , the warp fibers of one layer are depicted asreference number 342 and the warp fibers of another layer are depictedas reference number 344. As shown, the fibers 342 are oriented at90-degree angles relative to the fibers 344. Orienting the fibers atdifferent angles can increase the ability of the sealing member toresist enlargement of the orifice 332.

FIG. 17 shows the construction of a sealing member 330, according toanother embodiment. The sealing member 330 is this embodiment cancomprise a plurality of angular segments of material 346 (e.g., fabric)connected to each other along radially extending seams 348 (e.g., bysuturing or stitching). The angular segments 346 can increase theability of the sealing member to resist enlargement of the orifice 332.

In alternative embodiments, one or more features disclosed in any ofsealing members of FIGS. 14-17 can be combined with one or more featuresdisclosed in another one of the sealing members of FIGS. 14-17 . Forexample, a sealing member can comprise the angular segments 346 of FIG.17 and the toroid shaped layers 338 of FIG. 16 .

Referring again to FIGS. 10 and 11 , the connecting member 306 canextend from an inflow end of the valve component 304 to an outflow endof the support structure 302. The connecting member 306 can be made of asuitable biocompatible fabric (e.g., PET) or natural tissue. Theconnecting member 306 can be stitched or otherwise secured to the cover310 of the support structure 302 and the cover 324 of the valvecomponent 304. Alternatively, a single continuous piece of material canbe used to form the cover 310, the cover 324, and the connecting member306. During deployment of the valve assembly 300, the connecting member306 allows the valve component 304 to be pushed or pulled to a positioninside of the support structure 302, with the connecting member 306assuming an inverted state inside of the support structure 302, asfurther described below. Once fully deployed, the connecting member 306resists migration of the valve component 304 toward the left atriumagainst hemodynamic pressure during systole.

Referring to FIG. 11 , in some embodiments, the connecting member 306can comprise one or more apertures 307 and/or flaps 309 extendingthrough the connecting member 306. The apertures 307 and/or flaps 309can be spaced apart and/or distributed on the connecting member 306 invarious manners. The apertures 307 and/or flaps 309 can be configured toallow blood to flow from the left atrium, through the support structure302, through the connecting member 306, and into the left ventricle. Insome embodiments, the apertures 307 and/or flaps 309 can be configuredto allow the flow of blood in a one direction through connecting member(e.g., from the left atrium to the left ventricle) and to prevent theflow of blood in another direction through the connecting member 306(e.g., from the left ventricle to the left atrium).

As such, the apertures 307 and/or flaps 309 can allow at least someblood to flow through the valve assembly 300 during the deploymentprocedure. Referring to FIG. 22 , for example, the apertures 307 and/orflaps 309 can allow at least some blood to flow from the left atrium,through the connecting member 306, and into the left ventricle duringdeployment of the valve assembly 300 when the support structure 302 isexpanded and the valve component 304 is not yet expanded. The flaps 309can be configured to allow blood to flow from the left atrium to theleft ventricle via respective openings in the connecting member 306during diastole and then cover-up and close the respective openingsduring systole to block retrograde blood from flowing back into the leftatrium.

Referring to FIG. 25 , for example, the apertures 307 and/or flaps 309(not shown) can be closed, thus preventing blood from flowing throughthe apertures 307 and/or flaps 309 during diastole and systole, when thevalve structure 304 is positioned inside of the support structure 302and expanded and the connecting member 306 is inverted. Once the valvestructure 304 is expanded, the leaflets 328 of the valve structure 304can assume the blood-regulating function. Thus, configuring the valveassembly 300 in this manner allows at least some blood-flow through thevalve assembly 300 during the deployment procedure.

Allowing blood to flow through the valve assembly 300 during thedeployment procedure can advantageously allow a patient's heart tocontinue to at least partial function during the deployment procedure,thus reducing trauma to the patient. It can also advantageously allow aphysician to more easily position the valve assembly 300 because forcesacting on the valve assembly 300 caused by hemodynamic pressure arereduced when blood can pass through the valve assembly 300.

Notably, the valve component 304 defines a flow orifice for blood flowfrom the left atrium to the left ventricle, which flow orifice is notdependent on the size of the support structure 302. As such, the supportstructure 302 can be sized to fill the native annulus to prevent or atleast minimize paravalvular leakage while the valve component 304 can besized to provide a flow orifice (which is not dependent on the size ofthe support structure) that more closely mimics the hemodynamics of ahealthy native mitral valve. Thus, in certain embodiments, the valvecomponent is undersized relative to the support structure and defines aflow orifice much smaller than the lumen of the support structure. Thisis particularly advantageous when the patient has a relatively largemitral valve orifice that needs to be filled. In addition, providing avalve component that is undersized relative to the support structure,the size of the prosthetic leaflets 328 can be minimized, which improvesoverall leaflet function and durability. Another advantage of the valveassembly 300 is that the leaflets 328 can be positioned outside of thesupport structure 302 during delivery through a patient's vasculature,which minimizes the overall crimp profile of the assembly duringdelivery.

In addition, in particular embodiments, there are no metal componentsthat interconnect the frame 308 of the support structure to the frame322 of the valve component. Indeed, in the illustrated embodiment, theflexible sleeve is the only component interconnecting the supportstructure and the valve component. Minimizing the amount of metalcomponents in the valve assembly helps minimize the overall crimpprofile of the valve assembly and improves tracking of the valveassembly through the vasculature of the patient.

Turning now to FIGS. 18-25 , a method and apparatus for delivering avalve assembly 300 to the native mitral valve will now be described.FIGS. 18-21 show a delivery apparatus 400, according to one embodiment,configured to implant a valve assembly 300 having a self-expandablesupport structure 302 and a plastically-expandable valve component 304.The valve assembly 300 is mounted on the delivery apparatus 400 fortrans-septal delivery, although other delivery techniques can be used.

The delivery apparatus 400 can comprise a first shaft 402, a secondshaft 404 extending co-axially through the first shaft 404, an outersheath 406 extending co-axially over the first shaft 404, an inflatableballoon 408 mounted on a distal end portion of the second shaft 404, anda nose cone 410 mounted on the distal end portion of the second shaft404 distal to the balloon 408. The second shaft 404 can have a lumenconfigured to receive a guidewire. The first shaft 402, the second shaft404, and the sheath 406 can be axially moveable relative to each otherand can extend distally from a handle (not shown) at the proximal end ofthe delivery apparatus 400. Further details regarding the constructionof the delivery apparatus are disclosed in U.S. Publication No.2013/0030519, which is incorporated herein by reference.

When mounting the valve assembly 300 on the delivery apparatus 400 forinsertion into a patient's body, the valve assembly 300 is placed in theaxially extended configuration with the valve component 304 outside ofand axially spaced from the support structure 302. The valve component304 is crimped to a radially compressed state onto the balloon 408 andthe support structure 302 is crimped and inserted into the sheath 406 toretain the support structure in the radially compressed state. Ifdesired, the sheath 406 also can be advanced over the radiallycompressed valve component 304 (as shown in FIG. 18 ) to prevent directcontact between the patient's vasculature and the valve component 304.

As noted above, the delivery apparatus 400 and the valve assembly 300can be advanced into the heart via a trans-septal route by which thedelivery apparatus 400 and the valve assembly 300 are advanced into theright atrium (such as via the inferior or superior vena cava), acrossthe atrial septum, and into the left atrium. The delivery apparatus 400can then be used to position the support structure 302 within the nativemitral valve, after which the sheath 406 is retracted relative to thevalve assembly 300 and/or the valve assembly 300 is advanced distallyrelative to the sheath 406, allowing the support structure 302 toradially expand to its functional size (FIG. 19 ).

As best shown in FIG. 22 , the projections 318 of the support structure302 can engage and extend through the native leaflets 110 to anchor thesupport structure in place within the native mitral valve annulus 104.If the support structure has an atrial sealing member 315 (FIG. 7 ), thesealing member is positioned above the native annulus within the leftatrium, similar to the prosthetic valve 10 shown in FIG. 3 . Engagementand penetration of the leaflets 110 by the projections 318 can beaccomplished by expansion of the support structure 302, hemodynamicpressure, and/or a retraction force applied to the delivery apparatus400.

Following deployment of the support structure 302, the valve component304 is moved axially to a position within the support structure 302 byretracting the delivery apparatus 400, as shown in FIGS. 20 and 23 . Asthe valve component 304 is retracted within the support structure 302,the flexible connector 306 moves to an inverted state within the supportstructure. The length of the flexible connector 306 is selected suchthat the inflow end portion of the valve component can project upwardlybeyond the orifice of the sealing member 330 when the flexible connectoris pulled taut by retraction of the valve component relative to thesupport structure.

Referring to FIGS. 21 and 24 , the balloon 408 can then be inflated toradially expand the valve component 304 inside of the support structure302. The inflow end portion of the valve component 304 can expandagainst the inner peripheral edge (defining the orifice 332) of thesealing member 330 to help secure the valve component in place withinthe support structure. As noted above, in the illustrated embodiment,engagement of the valve component with the sealing member 330 and theflexible connector 306 anchor the valve component in place againsthemodynamic pressure. After expansion of the valve component 304, theballoon can be deflated and the delivery apparatus can be removed fromthe body, leaving the valve assembly 300 implanted in the native mitralvalve (FIG. 25 ).

In alternative embodiments, the valve assembly 300 can be delivered viaother delivery techniques, such as transventricular, transatrial,transfemoral, etc. Also, in alternative embodiments, the deliveryapparatus 400 can be configured to deploy a self-expandable valvecomponent 304 and/or a plastically-expandable support structure 302.

FIGS. 26-33 show an example of a prosthetic valve assembly 500,according to another embodiment. Referring to FIGS. 26-27 , theprosthetic valve 500 can generally comprise a support structure 502 anda valve component 504 supported by and/or within the support structure502, as further described below. The support structure 502 can beconfigured to securely engage a native annulus of a heart (e.g., similarto the manner shown in FIG. 3 ) to prevent the prosthetic valve assembly500 from migrating within the native annulus. The valve component 504can be configured for regulating the flow of blood in one directionthrough the prosthetic valve assembly 500, i.e., from an inflow end 506to an outflow end 508 of the prosthetic valve 500. The valve component504 can be separate component from the support structure 502 that isdelivered and deployed within the support structure 502 after thesupport structure 502 is implanted within a native valve, such as thenative mitral valve, as further described below.

Referring now to FIGS. 28-29 , the support structure 502 of theprosthetic valve assembly 500 can comprise a frame 510, ablood-impervious sealing member or sealing portion 512 substantiallycovering the frame 510, and a radially centrally disposed opening ororifice 514 extending axially through the sealing member 512.

As best shown in FIG. 30 , the frame 510 can comprise a main body 516and, optionally, an enlarged atrial flange 518 (not shown in FIGS.26-29, 31-33 ) extending both radially outward and axially upward froman atrial end 26 of the main body 22. The frame 510 is desirably coveredby the sealing 512, as further described below. Although not shown, theatrial flange 518 of the frame 510 also can be covered by the sealingmember 512, effectively forming an atrial sealing member (e.g., similarto atrial sealing member 17) of the support structure 502.

Referring again to FIGS. 28-29 , the main body 516 of the frame 510 cancomprise a plurality of interconnected angled struts 520, a plurality oftissue-engaging projections 522, and at least one positioning member 524(three in the illustrated embodiment) and can be configured in a mannersimilar to the main body 22 of the frame 12. In the illustratedembodiment, the end of each projection 522 has barb or hook portion 528,as best shown in FIG. 29 . In some embodiments, the projections can beconfigured without the hook portions (e.g., as shown in FIG. 4 ).

In some embodiments, main body 516 of the frame can be radially taperedin a direction extending from the inflow end to the outflow end (e.g.,the inflow end is slightly radially larger than in outflow end). Forexample, in one particular embodiment, the axial cross-sectional profileof the main body 516 can slope ten degrees radially inwardly (similar toa “V-shape”) from the inflow end to the outflow end of the main body516.

The frame 510 can be formed from a flexible, shape-memory material(e.g., Nitinol) to enable self-expansion from a radially compressedstate to a radially expanded state. As such, the support structure 502of the prosthetic valve 500 can be radially collapsible andself-expandable between a radially expanded state (e.g., FIGS. 26-29 )and a radially compressed state (not shown) to enable delivery andimplantation at the mitral valve region of the heart (or within anothernative heart valve). In alternative embodiments embodiments, the frame510 can be formed from a plastically-expandable material (e.g.,stainless steel or chromium alloys), and is configured to be expanded byan expansion device, such as an inflatable balloon.

The sealing member 512 of the support structure 502 can comprise anouter sleeve 530, an inner tube or sleeve 532, and first and secondsupport members or end walls 534, 536. The outer sleeve portion 530 canbe disposed around the outer circumferential surface of the main body516 of the frame 510 and can extend axially from the inflow end 506 tothe outflow end 508 of the prosthetic valve 500. The outer sleeve can becoupled or secured to the frame 510 such as by sutures or an adhesive,and the projections 522 of the frame 510 can penetrate through the outersleeve portion 530 (or extend through openings which can be formed inthe outer sleeve portion 530). The inner sleeve 532 can be disposedradially inwardly from the outer sleeve 530 and can extend axially fromthe inflow end 506 to the outflow end 508 of the prosthetic valveassembly 500 (e.g., substantially parallel to the outer sleeve 530).

The first end wall 534 can extend radially inwardly from a first endportion 538 of the outer sleeve 530 and has a respective innerperipheral edge defining a respective orifice. The second end wall 536can extend radially inwardly from a second end portion 542 of the outersleeve 530 and has a respective inner peripheral edge defining arespective orifice. The inner sleeve 532 can extend between the firstand second end walls and can have a first end portion 540 connected tothe inner peripheral edge of the first end wall 534 and a second endportion 544 connected to the inner peripheral edge of the second endwall 536. The first and second end walls 534, 536 can have respectiveopposing major surfaces facing in the axial direction and function toblock the flow of blood in the annular space between the frame 510 andthe valve component 504.

The first end portions 538, 540 of the sleeves 530, 532 and the firstend wall 534 and the second end portions 542, 544 of the sleeves 530,532 and the second end wall 536 can be secured together in various ways.For example, in some embodiments, the sleeves 530, 532 and the end walls534, 536 can be secured together by sutures, ultrasonic welding, and/oran adhesive. In other embodiments, one or more of the sleeves 530, 532and one or more of the end walls 534, 536 can be secured together byforming the sleeve(s) and the support member(s) from a single, unitarypiece of material.

The sealing member 512 extends radially inwardly from the frame 512 tothe inner sleeve 532 and axially from the inflow end 506 to the outflowend 508, thereby forming the lumen 514 which extends axially through thesupport structure 502 for receiving the valve component 504. As aresult, the support structure 502 can be configured such that the frame510 has an outer diameter that is substantially the same or slightlylarger than the inner diameter of the native annulus and the orifice 514has an inner diameter that is smaller than the inner diameter of thenative annulus. This can advantageously allow the valve component 504 tobe smaller than the native annulus (see, e.g., FIG. 25 ) for desiredhemodynamics while the support structure 502 can be sized to fill thenative annulus and prevent or at least minimize paravalvular leakagebetween the native annulus and the valve assembly 500.

The sealing member 512 can be formed from various suitableblood-impervious materials such as polyethylene terephthalate (“PET”)fabric. As such, when the support structure 502 is disposed and securedin a native annulus (e.g., similar to the support structure 302 in FIG.22 ), the support structure 502 can direct the flow of blood through thevalve component 504 (which can be disposed in the orifice 514, as bestshown in FIGS. 26-27 ) and can at least substantially prevent the flowof blood through and/or around the support structure 502.

The support structure 502 can be configured such that the inner sleeve532 and/or the end walls 534, 536 are relatively non-expansible ornon-extensible in the radial direction and can securely support thevalve component 504 when the valve component 504 is deployed in theorifice 514, as shown, for example, in FIGS. 26-27 and further describedbelow. This can be accomplished, for example, by orienting and/orconfiguring the fabric of the inner sleeve 532 and/or the end walls 534,536 as described above with respect to the embodiments of the sealingmember 330 of FIGS. 14-17 . In some embodiments, the support structure502 can include struts or ribs extending radially between the outersleeve 530 and the inner sleeve 532. The struts or ribs can be spacedaxially and/or circumferentially relative to each other within the spacedefined by the inner sleeve, outer sleeve, and the end walls of thesealing member.

Referring now to FIGS. 26-27 , the valve component 504 can compriseframe 546 and a valve structure 548 having a plurality of leaflets 550(three in the illustrated embodiment). As noted above, the valvecomponent 504 can be configured for regulating the flow of blood from aninflow end 506 to an outflow end 508 of the prosthetic valve assembly500. The valve component 504 can be configured similar to the valvecomponent 304. The valve component 504 can further include an outersleeve or cover (similar to cover 324) to enhance engagement with theinner surface of the inner sleeve 532. The frame 546 can be made fromany of the self-expandable, shape-memory materials orplastically-expandable materials described above.

The prosthetic valve assembly 500 can be delivered and or deployed invarious ways and/or with various delivery apparatuses. For example, insome embodiments, the prosthetic valve 500 can be releasably attached tothe delivery apparatus 400, delivered trans-septally, and deployedwithin a native mitral valve annulus similar to the manner shown inFIGS. 18-25 and described above. In other words, in such embodiments,the prosthetic valve assembly 500 can be delivered and deployed with onedelivery apparatus.

In other embodiments, the support structure 502 of the prosthetic valveassembly 500 can be delivered and deployed using a first deliveryapparatus and a delivery approach (e.g., trans-septally), and then thevalve component 504 of the prosthetic valve assembly 500 can bedelivered and deployed using a second delivery apparatus and the samedelivery approach (e.g., trans-septally).

For example, the support structure 502 of the prosthetic valve assembly500 can be radially compressed and retained within a delivery cylinderof a first delivery apparatus (not shown). The first delivery apparatuscan be inserted into a patient's body and advanced to or adjacent anative mitral valve annulus using trans-septal delivery approach. Thesupport structure 502 can then be deployed from within the deliverycylinder, which can allow the support structure 502 to radially expand.The support structure 502 can then be desirably positioned and securedwithin the native annulus and released from the first deliveryapparatus. The first delivery apparatus can then be removed from thepatient's body, leaving the support structure 502 securely positioned inthe native mitral valve annulus.

Referring to FIG. 31 , the valve component 504 can be crimped onto aballoon portion 602 of a second delivery apparatus 600. Although notshown, the second delivery apparatus 600 can comprise various othercomponents such a delivery cylinder, etc, can have the same constructionas the delivery apparatus 400. The second delivery apparatus 600 can beinserted into a patient's body and advanced to or adjacent the nativemitral valve annulus using a trans-septal delivery approach.

As best shown in FIGS. 32-33 , the second delivery apparatus 600 can beadvanced into and/or through the orifice 514 of the support structure502 such that the valve component 504 is disposed within the orifice514. As shown in FIG. 33 , the valve component 504 can be deployed, andthus secured to the support structure 502, by inflating the balloonportion 602 of the second delivery apparatus 600. This can cause thevalve component 504 to radially expand against the inner sleeve 532 ofthe support structure 502, thus securing the valve component 504 to thesupport structure 502, as best shown in FIGS. 26 and 27 . The balloonportion 602 of the second delivery apparatus 600 can then be deflated,and the second delivery apparatus can be removed from the patient'sbody, leaving the prosthetic valve 500 securely positioned in the nativemitral valve annulus.

Although not shown, in some embodiments, the support structure 502 cancomprise a temporary valve component (e.g., temporary leaflets withinthe orifice 514) which can be configured to regulate the flow of bloodin one direction for the duration between deploying the supportstructure 502 and deploying the valve component 504. The temporary valvecomponent can be configured to be displaced (e.g., crushed) when thevalve component 504 is radially expanded within the orifice 514 of thesupport structure 502, and the valve component 504 can assume regulatingthe flow of blood in one direction. The temporary leaflets can berelatively thinner and less durable than the leaflets of the valvecomponent as they are intended to function for a relatively short perioduntil the valve component 504 is implanted.

In other embodiments, the support structure 502 of the prosthetic valveassembly 500 can be delivered and deployed using a first deliveryapparatus and a first delivery approach (e.g., trans-septally), and thevalve component 504 of the prosthetic valve assembly 500 can bedelivered and deployed using a second delivery apparatus and a seconddelivery approach (e.g., transventricularly). This can advantageouslyreduce the implantation procedure time and/or reduce the durationbetween the deployment of the support structure 502 and the valvecomponent 504 because the valve component 504 can inserted into thesupport structure 502 without having to remove the first deliveryapparatus from the patient's body and then insert and advance the seconddelivery apparatus into the patient's body via the same delivery path.

FIGS. 34-35 show an example of a prosthetic valve assembly 700,according to another embodiment. The prosthetic valve assembly 700 cangenerally comprise a support structure 702 and a valve component 704coupled or secured within the support structure 702, as furtherdescribed below. The support structure 702 can be configured to securelyengage a native annulus of a heart (e.g., similar to the manner shown inFIG. 3 ) to prevent the prosthetic valve assembly 700 from migratingwithin the native annulus. The valve component 704 can be configured forregulating the flow of blood in one direction through the prostheticvalve assembly 700, i.e., from an inflow end 706 to an outflow end 708of the prosthetic valve assembly 700.

The support structure 702 of the prosthetic valve assembly 700 cancomprise a frame 710, a blood-impervious sealing member 712substantially covering the frame 710, and a radially centrally disposedopening or orifice 714 extending axially through the support structure702. The support structure 702 can be configured similar to the supportstructure 502 of the prosthetic valve assembly 500. The frame 710 cancomprise plurality of tissue-engaging projections 716 and one or morepositioning members 718 (three in the illustrated embodiment). The clothportion 712 can comprise an outer sleeve 720, an inner sleeve 722, andfirst and second support members or end walls 724, 726.

The valve component 704 can comprise a plurality of leaflets 728 (threein the illustrated embodiment). The valve component 704 can be coupledor secured to the inner sleeve 722 of the support structure 702 invarious ways such as by sutures 730 and/or by an adhesive.

In some embodiments, the leaflets 728 can, for example, be prostheticand/or bio-prosthetic leaflets configured to permanently regulate theflow of blood in one direction. In this manner, the prosthetic valve 700can be configured substantially similar to the prosthetic valve assembly500 except the valve component 704 of the prosthetic valve 700 does nothave a separate frame like the frame 546 of the valve component 504;rather, the valve component 704 and the support structure 702 arepre-assembled as a single unit. As such, the support structure 702 andthe valve component 704 of the prosthetic valve 700 can be deployedsimultaneously rather than sequentially like the support structure 502and the valve component 504 of the prosthetic valve assembly 500.

In other embodiments, the leaflets 728 can, for example, be temporaryleaflets (e.g., cloth leaflets) configured to temporarily regulate theflow of blood in one direction and to be displaced by a later-deployedvalve component which can assume regulating the flow of blood in onedirection. It should be noted that in any of the disclosed embodiments,the leaflets can be temporary leaflets configured to be displaced by alater-deployed valve structure having permanent leaflets.

FIGS. 36-37 show an example of a prosthetic valve 800, according toanother embodiment. The prosthetic valve 800 can generally comprise asupport structure 802 and a valve component 804 coupled or securedwithin the support structure 802 by one or more connecting members orstruts 806 (three in the illustrated embodiment). The support structure802 can be configured to securely engage a native annulus of a heart(e.g., similar to the manner shown in FIG. 3 ) to prevent the prostheticvalve 800 from migrating within the native annulus. The valve component804 can be configured for regulating the flow of blood in one directionthrough the prosthetic valve 800, i.e., from an inflow end 808 to anoutflow end 810 of the prosthetic valve 800.

The support structure 802 can comprise a frame 812 and ablood-impervious sealing member (e.g., formed from a fabric or cloth)(not shown for purposes of illustration). The frame 812 can beconfigured similar to, for example, the frame 500 and can comprise aplurality of interconnected struts 814, a plurality of tissue-engagingprojections 815, and one or more first positioning members 816 (three inthe illustrated embodiment) axially extending from the inflow end 808 ofthe frame 812. The struts 814 can configured to form cells 818 which canbe arranged in circumferentially extending rows (e.g., two rows in theillustrated embodiment).

Although not shown, the sealing member can be configured similar to thesealing member 512 and can comprise an outer sleeve extendingcircumferentially around and covering an outer surface of the frame 812,an inner sleeve disposed radially inward from the outer sleeve and thean inner surface of the frame 812, and first and second end wallsextending radially between and connecting first and second ends of thesleeves, respectively.

In some embodiments, the inner sleeve of the sealing member can besubstantially cylindrically shaped and can have an inner diameter thatis substantially the same as the inner diameter of a frame 820 of thevalve component 804. As such, the inner sleeve can form a substantiallycylindrical orifice or lumen which extends axially from the inflow end808 of the prosthetic valve to or adjacent an orifice or lumen 822 ofthe valve component 808.

In other embodiments, the inner sleeve of the cloth portion can besubstantially conically shaped and can have a first inner diameter atthe first end of the inner sleeve which is substantially the same as theinner diameter of inflow end 808 of the frame 812. From the first end,the inner sleeve can taper radially inwardly and can have a second innerdiameter at the second end of the inner sleeve which is substantiallythe same as the inner diameter as an inner diameter of a frame 820 ofthe valve component 804. As such, the inner sleeve can form asubstantially conical orifice which extends axially from the inflow end808 of the prosthetic valve to or adjacent the orifice 822 of the valvecomponent 808 (similar to a funnel).

The valve component 804 of the prosthetic valve 800 can be configuredsimilar to the valve component 502. As noted above, the valve component804 can comprise the frame 820 and the orifice 820. Although not shown,the valve component can comprise a valve structure which can beconfigured (e.g., with leaflets) for regulating the flow of blood in onedirection through the prosthetic valve 800 from the inflow end 808 tothe outflow end 810 of the prosthetic valve 800.

The frame 820 can be formed by a plurality of interconnected struts 824.The struts 824 can be configured to form cells 826 which can be arrangedin circumferentially extending rows (e.g., one row in the illustratedembodiment). In some embodiments, the frame 820 can have more than onerow of cells 826. The frame 820 can also have one or more secondpositioning members 828 (three in the illustrated embodiment) axiallyextending from the outflow end 810 of the frame 820. The secondpositioning members 828 can be used, for example, in lieu of or inaddition to the first positioning members 816 to connect the outflow end810 of the prosthetic valve to a delivery apparatus.

The frame 820 of the valve component 804 can have an outer diameter thatis smaller than the inner diameter of the frame 812 of the supportstructure 802. As such, the frame 820 can securely engage a nativeannulus (e.g., a native mitral valve annulus) and the valve componentcan be smaller than the native annulus and supported by the frame 820 ofthe support structure 802.

The struts 806 of the prosthetic valve 800 can extend between and can beconnected or coupled to the frame 812 of the support structure 802 andthe frame 820 of the valve component 804. The struts 806 can beconfigured to extend axially from the frame 812 toward the outflow end810 of the prosthetic valve 800 (as best shown in FIG. 36 ) and toextend radially inwardly (as best shown in FIG. 37 ). In the illustratedembodiment, the struts 806 are connected to an outflow end portion ofthe frame 812 at first ends of the struts and connected to an inflow endportion of the frame 820 at second ends of the struts. In someembodiments, a length and/or positioning of the struts 806 can beconfigured such that the valve component 804 at least partially axiallyoverlaps or is nested within the support structure 802. In otherembodiments, the length and/or positioning of the struts 806 can beconfigured such that the valve component 804 does not substantiallyaxially overlap or nest within the support structure 802. In someembodiments, the length and/or the angle of the struts 806 canconfigured to increase or decrease the radial distance between the valvestructure 802 and the valve component 804.

The frames 812, 820 can be formed from any suitable self-expanding,shape-memory materials or plastically-expandable materials describedabove. In some embodiments, both the support structure and the valvecomponent are self-expandable or are both plastically expandable. Inother embodiments, one of the support structure and the valve componentis self-expandable and the other is plastically-expandable by anexpansion device such as a balloon.

The struts 806 can be connected or coupled to the frames 812, 820 invarious ways. For example, as shown in the illustrated embodiment, thestruts 806 can be connected to the frames 812, 820 by forming the struts806 and the frames 812, 820 from a single unitary piece of material.This can be accomplished, for example, by laser cutting a metal (e.g.,Nitinol) tube, and shape setting the struts 806 and the frames 812, 820in their respective configurations. In other embodiments, the struts 806can be coupled to connected to the frames 812, 820 by welding,fasteners, and/or an adhesive.

Although not shown, the prosthetic valve 800 can be attached to adelivery apparatus, inserted into a patient's body, and deployed at animplantation site (e.g., a native mitral valve annulus) in various ways.For example, the prosthetic valve 800 can be radially compressed andretained within a delivery cylinder of a delivery apparatus. Thedelivery apparatus can be inserted into a patient's body and advanced toor adjacent a native mitral valve annulus using trans-septal deliveryapproach. The prosthetic valve 800 can then be deployed from within thedelivery cylinder, which can allow the prosthetic valve 800 to radiallyexpand and engage the tissue of the native mitral valve annulus. Theprosthetic valve 800 can then be desirably positioned and secured withinthe native mitral valve annulus and released from the delivery apparatus(see, e.g., FIG. 3 ). The delivery apparatus can then be removed fromthe patient's body, leaving the prosthetic valve 800 securely positionedin the native mitral valve annulus.

FIGS. 38-41 show an exemplary embodiment of a prosthetic heart valvedelivery assembly 900. Referring to FIG. 41 , the delivery assembly 900can comprise an expandable prosthetic heart valve 902 and a deliveryapparatus 904.

The prosthetic valve 902 can configured in a manner similar to theprosthetic heart valves and/or assemblies 10, 300, 500, 700, 800. Theprosthetic valve 902 can be configured to be radially expandable from acompressed state (e.g., as shown in FIGS. 38-40 ) to an expanded state(e.g., as shown in FIG. 41 ), and vice versa. In some embodiments, asshown, the prosthetic heart valve 902 can be a self-expanding valve. Inother embodiments, the prosthetic heart valve 902 can be mechanicallyexpanding valve (e.g., a balloon expandable valve). The prosthetic heartvalve 900 can be releasably coupled to the delivery apparatus 904, asfurther described below.

Referring still to FIG. 41 , the delivery apparatus 904 can comprise ahandle 905, a first catheter 906, a second catheter 908, and a thirdcatheter 910. Proximal end portions of the catheters 906, 908, 910 canbe coupled to the handle 905 and can extend distally away from thehandle 905 toward distal end portions of the catheters 906, 908, 910.The second and third catheters 908, 910, can extend coaxially throughthe first catheter 908, and the third catheter 910 can extend coaxiallythrough the second catheter 908. The catheters 906, 908, 910 can beindependently movable (e.g., axially and/or rotationally) relative toeach other.

The handle 905 can be used to adjust the positioning of the prostheticheart valve 902 and the delivery apparatus 904 relative to a patient'sbody (e.g., the patient's heart). In some embodiments, the handle 905can comprise a plurality of control knobs (not shown) (e.g., one knobfor each of the catheters 906, 908, 910), and the control knobs can beconfigured to adjust the relative positioning of the catheters 906, 908,910.

In some embodiments, the handle 905 and the catheters 906, 908, 910 canbe configured to translate relative rotational movement (e.g., clockwiseand counterclockwise movement) between the catheters 906, 908, 910 atthe proximal end portions of the catheters 906, 908, 910 into relativeaxial movement (e.g., proximal and distal relative movement) between thecatheters 906, 908, 910 at the distal end portions of the catheters 906,908, 910. This can be accomplished, for example, by configuring thedelivery apparatus 904 similar to the manner described in U.S. Pat. No.8,652,202, which is incorporated herein by reference.

Referring to FIG. 38 , the first catheter 906 can comprise an elongateshaft having a sleeve or sheath portion 912 disposed at or near thedistal end portion 914 of the first catheter 906. The sheath portion 912of the first catheter 906 can be configured to compress a portion of thesecond catheter 908 and/or retain a portion of the second catheter 906in a compressed state, as further described below.

The second catheter 908 can comprise an elongate shaft have a sleeve orsheath portion 916 and a plurality of flexible paddles or arms 918(e.g., two in the illustrated embodiment) disposed at or near the distalend portion 920 of the second catheter 908. The sheath portion 916 ofthe second catheter 908 can be used to compress and/or retain theprosthetic heart valve 902 in the compressed state, as further describedbelow. The flexible arms 918 of the second catheter 908 can be coupledto and extend radially outward from the sheath portion 916 of the secondcatheter 908.

The flexible arms 918 of the second catheter 908 can be configured so asto be movable from one configuration to one or more otherconfigurations, and vice versa. For example, the flexible arms 918 canbe configured to be movable from a first configuration (e.g., acompressed configuration, as shown in FIG. 38 ) to a secondconfiguration (e.g., a resting or undeflected configuration, as shown inFIG. 39 ) to a third configuration (e.g., a leaflet-retentionconfiguration, as shown in FIGS. 40-41 ), and vice versa.

As shown in FIG. 38 , in the first configuration, the flexible arms 918can be angled axially away from the distal end portion 920 of the secondcatheter 908 and compressed against the sheath portion 916 of the secondcatheter 908. With the flexible arms 918 in the first configuration, theflexible arms 918 of the second catheter 908 can be positioned withinthe sheath portion 912 of the first catheter 906. The sheath portion 912of the first catheter 906 can be configured to retain the flexible arms918 of the second catheter 908 in the first configuration.

As shown in FIG. 39 , the flexible arms 918 can be moved from the firstconfiguration to the second configuration by exposing the flexible arms918 from the sheath portion 912 of the first catheter 906. This can beaccomplished by proximally retracting the first catheter 906 relative tothe second catheter 908 (and/or by distally advancing the secondcatheter 908 relative to the first catheter 906) such that the flexiblearms 918 extend from the distal end portion 914 of the first catheter906. This allows the flexible arms 918 to expand radially outwardly awayfrom the sheath portion 916 of the second catheter 908.

As shown in FIG. 40 , the flexible arms 918 can be moved from the secondconfiguration to the third configuration by moving the sheath portion912 of the first catheter 906 back over the flexible arms 918. This canbe accomplished by proximally retracting the second catheter 908relative to the first catheter 906 (and/or by distally advancing thefirst catheter 906 relative to the second catheter 908) such thatproximal portions 922 of the flexible arms 918 are disposed radiallywithin the sheath portion 912 of the first catheter 906. This causes theflexible arms 918 to press against the sheath portion 912 at the distalend portion 914 of the first catheter 906, which in turn causes thedistal portions 924 of the flexible arms 918 to initially move radiallyoutwardly away from the sheath portion 916 of the second catheter 908.As the second catheter 908 is retracted farther proximally relative tothe first catheter 906 (i.e., as distal portions 924 of the flexiblearms 918 move toward the distal end portion 914 of the first catheter906), the sheath portion 912 of the first catheter 906 causes theflexible arms 918 to pivot distally away from the sheath portion 916 ofthe second catheter 908 and the distal portions 924 of the flexible arms918 to radially converge toward each other. The relative spacing betweenthe distal portions 924 of the flexible members can be increased bydistally advancing the second catheter 908 relative to the firstcatheter 906 (and/or by proximally retracting the first catheter 906relative to the second catheter 908).

In alternative embodiments, the flexible arms 918 of the second catheter908 can be configured to extend radially outwardly and distally awayfrom the distal end 920 of the second catheter 908 (i.e., in theopposite direction of the flexible arms 918 shown in FIG. 38 ) when theflexible arms 918 are in the first configuration (i.e., the compressedconfiguration). In such embodiments, the flexible arms 918 can beconfigured to expand radially outwardly relative to each other and to beangled distally relative to the distal end portion 920 of the secondcatheter 908 when the flexible arms 918 are deployed from the sheathportion 912 of the first catheter 906. The relative distance betweendistal portions 924 of the flexible arms can be adjusted by moving thefirst and second catheters 906, 908 relative to each other, as furtherdescribed above.

In some embodiments, the flexible arms 918 can be operably coupled tothe handle 905. For example, the delivery apparatus 904 can includelinkage and/or wires (not shown) that extend proximally (e.g., throughthe first and/or second catheters 906, 908) from the flexible arms 918to or adjacent the handle 905. The linkage and/or wires can beconfigured to control, move, and/or adjust the positioning,configuration, and/or gripping force (i.e., the compressive forceapplied by the flexible arms 918 on an object or objects (e.g., nativeleaflets) disposed between the flexible arms 918) of the flexible arms918. In some embodiments, the linkage and/or wires can be configuredsuch that the flexible arms 918 can be independently operable relativeto each other (e.g., each flexible arm 918 can be operably coupled to aseparate linkage and/or wire). In some embodiments, the linkage and/orwires can be operably coupled to one or more control knobs that aredisposed on the handle 905 or other portion of the delivery apparatus904. The control knobs can be configured to control, move, and/or adjustthe linkage and/or wires and thus the flexible arms 918.

The flexible arms 918 can also include one or more radiopaque elements(not shown). The radiopaque elements can be disposed on the flexiblearms 918 and can allow a physician to monitor the positioning of theflexible arms 918 during an implantation procedure. In some embodiments,the radiopaque elements can be integrally formed with the flexible arms918 (e.g., co-molded). In other embodiments, the radiopaque elements canbe separately formed and then attached to the flexible arms 918 such aswith an adhesive. In some embodiments, the radiopaque elements can bedisposed on the distal portions 924 of the flexible arms 918.

In some embodiments, as shown, the distal portions 924 of the flexiblearms 918 can be formed as a paddle-like portion that is relativelylarger than the proximal portions 922 of the flexible arms 918. Thesepaddle-like distal portions 924 can provided a relatively large surfacearea that can contact and or grip native leaflets of heart.

The flexible arms 918 can be formed from various materials, such asmetals, polymers, composites, etc. For example, in some embodiments, theflexible arms 918 can be formed from relatively elastic materials suchas stainless steel, Nitinol, shape-memory polymers, etc. The flexiblearms 918 can include covers made from a relatively soft material, suchas cloth, fabric, or natural tissue, to reduce trauma to the surroundingheart tissue and/or to increase friction between the flexible arms 918and native heart tissue (e.g., native leaflets).

Referring to FIGS. 40 and 41 , the third catheter 910 can comprise anelongate shaft having a distal end portion 926. The distal end portion926 of the third catheter 910 can be releasably coupled to theprosthetic heart valve 902 in various ways such as with sutures,interlocking mating features, etc. Additional details regardingreleasably coupling a prosthetic heart valve to a delivery apparatus canbe found, for example, in U.S. Pat. No. 8,652,202. As such, the thirdcatheter 910 can be used to move the prosthetic heart valve 902 relativeto the first and/or second catheters 906, 908. This can be accomplished,for example, by moving the third catheter 910 axially (i.e., proximallyand/or distally) relative to the first and/or second catheters 906, 908.

In some embodiments, the delivery apparatus 904 can be configured todeliver a prosthetic heart valve to a native heart valve of a patient.The delivery apparatus 904 can also be configured for various types ofdelivery approaches (e.g., transapical, transventricular, transseptal,transfemoral, etc.). For example, FIGS. 38-41 show the deliveryapparatus 904 being used to deliver the prosthetic heart valve 902 to anative mitral valve 1002 of a patient's heart 1000 using a transapicalapproach.

The prosthetic heart valve 902 can be implanted in the native mitralvalve 1002 by radially compressing the prosthetic heart valve 902 to thecompressed configuration and positioning the prosthetic heart valve 902within the sheath portion 916 of the second catheter 906, as shown inFIG. 38 . As also shown in FIG. 38 , the flexible arms 918 of the secondcatheter 908 can be radially compressed to the first configuration andpositioned within the sheath portion 912 of the first catheter 906.

With the delivery assembly 900 in this configuration, a distal endportion of the delivery assembly 900 can be advanced into the leftventricle 1004 of the patient's heart 1000. This can be accomplished,for example, by inserting an introducer (not shown) into the leftventricle 1004 and inserting the distal end portion of the deliveryassembly 900 into and through the introducer and into the left ventricle1004. As shown in FIG. 38 , the distal end portion of the deliveryassembly 900 can be positioned adjacent the patient's native mitralvalve leaflets 1006. The flexible arms 918 of the second catheter 908can be moved from the first configuration to the second configuration byproximally retracting the first catheter 906 relative to the secondcatheter 908, as shown in FIG. 39 .

The native leaflets 1006 can be captured or secured between the flexiblearms 918 by moving the flexible arms 918 from the second configurationto the third configuration by proximally retracting the second catheter908 relative to the first catheter 906, as shown in FIG. 40 . In thisconfiguration, the flexible arms 918 can be positioned against theventricular side of the native leaflets 1006 and can hold or stabilizethe native leaflets 1006, as shown in FIGS. 40 and 41 , for subsequentdeployment of the prosthetic heart valve 902.

While holding the native leaflets 1006 with the flexible arms 918, theprosthetic heart valve 902 can be deployed from the sheath portion 916of the second catheter 908 by distally advancing the third catheter 910relative to the first and second catheters 906, 906 such that theprosthetic heart valve 902 is disposed distally relative to the distalend portions 914, 902 of the first and second catheters 906, 908,respectively. The prosthetic heart valve 902 can then radially expand(and/or be expanded) from the compressed configuration to the expandedconfiguration (e.g., by self-expanding and/or mechanically expanding),as shown in FIG. 41 . The prosthetic heart valve 902 can then bedesirably positioned relative to the native mitral valve 1002 by movingthe prosthetic heart valve 902 with the third catheter 910. Theprosthetic heart valve 902 can be secured to the native leaflets 1006and/or the native mitral valve annulus, for example, using securingelements 928 (e.g., similar to the projections 36 of the prostheticvalve 10).

Holding the native leaflets 1006 while the prosthetic heart valve 902 isdeployed, positioned, and/or secured can make it relatively easier forthe physician to quickly, securely, and accurately position theprosthetic heart valve 902 in the native mitral valve 1002 because themovement of the native leaflets 1006 is restricted. This can, forexample, help to ensure that the securing elements 928 of the prostheticheart valve 902 penetrate the tissue of the native leaflets 1006. Inaddition, the native leaflets 1006 can be drawn toward each other andagainst the outer surface of the prosthetic heart valve 902 bydecreasing the distance between the flexible arms 918 (throughmanipulation of the catheters 906, 908) to enhance the attachment of thesecuring elements 928 of the prosthetic heart valve to the nativeleaflets 1006.

Once the prosthetic heart valve 902 is secured, the prosthetic heartvalve 902 can be released from the third catheter 910, and the distalend portions of the second and third catheters 908, 910 can beproximally retracted into the sheath portion 912 of the first catheter906. The delivery apparatus 904 can then be proximally retracted throughthe introducer and removed from the patient's body.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. We thereforeclaim as our invention all that comes within the scope and spirit ofthese claims.

The invention claimed is:
 1. A prosthetic valve assembly comprising: aradially expandable and compressible support structure, the supportstructure comprising a first frame and an annular sealing member,wherein the first frame includes a lumen extending from an inflow end toan outflow end, wherein the sealing member extends radially inwardlyinto the lumen of the first frame and comprises a radially extendingannular first end wall defining a first orifice, a radially extendingannular second end wall axially spaced from the first end wall anddefining a second orifice, and a tubular inner sleeve comprising aninflow end and an outflow end extending axially from the first orificeof the first end wall to the second orifice of the second end wall andbeing spaced radially inwardly from the inflow end of the first frameand the outflow end of the first frame; a gap extending radially betweenthe inner sleeve of the sealing member and the first frame of thesupport structure and extending axially toward the second end wall; anda radially expandable and compressible valve component, the valvecomponent comprising a second frame and a valve structure supportedinside of the second frame for permitting blood flow through the valvecomponent in one direction and blocking blood flow in the oppositedirection, wherein the valve component is configured to expand withinand engage the inner sleeve of the sealing member, and wherein the firstend wall extends radially inwards from the inflow end of the first frameto the inflow end of the tubular inner sleeve and the second end wallextends radially inwards from the outflow end of the first frame to theoutflow end of the tubular sleeve.
 2. The prosthetic valve assembly ofclaim 1, wherein the first end wall, the second end wall, and the innersleeve of the sealing member comprises fabric.
 3. The prosthetic valveassembly claim 1, wherein the sealing member comprises an outer sleeveextending over an outer surface of the first frame of the supportstructure from the first end wall to the second end wall.
 4. Theprosthetic valve assembly of claim 1, wherein the gap extends axiallyalong the valve component for a distance of greater than half of anaxial length of the valve component.
 5. The prosthetic valve assembly ofclaim 1, wherein the gap extends axially from the first end wall to thesecond end wall.
 6. The prosthetic valve assembly of claim 1, whereinthe support structure comprises a plurality of projections secured tothe first frame of the support structure and configured to penetratetissue of native heart valve leaflets.
 7. The prosthetic valve assemblyof claim 6, wherein the projections have first portions and secondportions, wherein the first portions extend radially outwardly from thefirst frame of the support structure and axially toward the inflow endof the first frame of the support structure, and wherein the secondportions extend radially inwardly from the first portions and axiallytoward the outflow end of the first frame of the support structure. 8.The prosthetic valve assembly of claim 1, wherein the first frame of thesupport structure and the second frame of the valve component comprisemetal.
 9. The prosthetic valve assembly of claim 1, wherein the inflowend of the first frame comprises a radially extending flange configuredto engage an atrial cusp of a patient's native vasculature when thevalve assembly is in a fully-deployed configuration.
 10. The prostheticvalve assembly of claim 1, wherein the first frame comprises a pluralityof projections secured to the frame of the support structure andconfigured to penetrate tissue of native heart valve leaflets.
 11. Aprosthetic valve assembly comprising: a radially expandable andcompressible support structure, the support structure comprising anannular frame having a first lumen extending from an inflow end to anoutflow end and a plurality of tissue engaging projections extendingradially outwards from the annular frame; an annular sealing memberextending radially inwardly into the lumen of the frame and having aninner peripheral portion defining an orifice; and a radially expandableand compressible tubular valve component coupled to the sealing memberinside of the support structure, the valve component comprising aplurality of leaflets configured to permit blood flow through the valvecomponent in one direction and block blood flow in the oppositedirection, wherein the sealing member comprises a first end walldefining a first orifice, a second end wall axially spaced from thefirst end wall and defining a second orifice, and a tubular inner sleeveextending from the first orifice of the first end wall to the secondorifice of the second end wall, wherein the tubular inner sleeve definesa second lumen that is concentric with and positioned radially inwardsof the first lumen, wherein the valve component is mounted inside of theinner sleeve, and wherein the support structure and the valve componentdefine a radially and axially extending gap between the frame, thesupport structure, and the valve component along an entire axial lengthof the valve component when the valve component is mounted within theinner sleeve of the support structure.
 12. The prosthetic valve assemblyof claim 11, wherein the frame of the support structure is a firstframe, wherein the valve component comprises a second frame, and whereinthe leaflets are mounted inside of the second frame of the valvecomponent.
 13. The prosthetic valve assembly of claim 11, wherein thereare no metal components connecting the frame of the support structure tothe valve component.
 14. The prosthetic valve assembly of claim 11,wherein the frame of the support structure and the valve component areconnected to each other only by fabric.
 15. A prosthetic valve assemblycomprising: a radially expandable and compressible support structure,the support structure comprising an annular frame having a lumenextending from an inflow end to an outflow end; a blood-impermeabletubular sleeve disposed inside of the frame of the support structure,the sleeve having a lumen extending from an inflow end to an outflowend, wherein the inflow end of the sleeve is spaced radially inward ofand axially aligned with the inflow end of the frame of the supportstructure and the outflow end of the sleeve is spaced radially inward ofand axially in line with the outflow end of the frame of the supportstructure; and a plurality of leaflets supported inside the lumen of thesleeve and configured to permit blood flow through the lumen of thesleeve in one direction and block blood flow in the opposite direction,wherein the support structure and the tubular sleeve are separated by agap extending radially between the tubular sleeve and the supportstructure and extending axially between the inflow end of the supportstructure and the outflow end of the support structure.
 16. Theprosthetic valve assembly of claim 15, wherein the leaflets are stitchedto the sleeve.
 17. The prosthetic valve assembly of claim 15, whereinthe leaflets are supported inside of another annular frame that isdisposed within the sleeve.
 18. The prosthetic valve assembly of claim15, further comprising first and second end walls that are spacedaxially apart from each other, the first end wall extending radiallyinwardly from the frame of the support structure and having a firstinner peripheral edge defining a first orifice and secured to the inflowend of the sleeve, the second end wall extending radially inwardly fromthe frame of the support structure and having a second inner peripheraledge defining a second orifice and secured to the outflow end of thesleeve.
 19. The prosthetic valve assembly of claim 15, wherein thesupport structure comprises a plurality of projections secured to theframe of the support structure and configured to penetrate tissue ofnative heart valve leaflets.
 20. The prosthetic valve assembly of claim19, wherein the sleeve is formed of fabric.